FDA Adverse Event
Malfunction
Summary report: N
EASYTRAK 2
MDR report key: 4132245
·
Received October 1, 2014
Report
- Report Number
- 2124215-2014-15916
- Event Type
- Malfunction
- Date Received
- October 1, 2014
- Date of Event
- May 10, 2014
- Report Date
- July 24, 2014
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NIK
- PMA / PMN Number
- P010012
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS. THERE WAS A CONCERN THE LV LEAD HAD FRACTURED. THE LEAD WAS REPROGRAMMED TO UNIPOLAR WITH APPROPRIATE SENSING AND CAPTURE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 613126 | EASYTRAK 2 | IMPLANTABLE LEAD | NIK | CPI - DEL CARIBE | 4542 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | 4542| 4537| H210| N141| 0137| 4136 |